Pulmonary artery implant apparatus and methods of use thereof

ABSTRACT

The present invention relates to an implantable apparatus and methods of use thereof for treating congestive heart failure. An apparatus of this invention may be anchored by implantation of a section of the apparatus within in a branch pulmonary artery, for example the left pulmonary artery, which then positions and anchors another section, for example a device frame section of the apparatus within the main pulmonary artery. A medical device may be attached to the anchored device frame.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/327,075 filed on Jan. 18, 2017, which is a National Phase of PCTPatent Application No. PCT/IL2015/050745 having International FilingDate of Jul. 20, 2015, which claims the benefit of priority under 35 USC§ 119(e) of U.S. Provisional Patent Application No. 62/026,656 filedJul. 20, 2014. The contents of the above applications are allincorporated by reference as if fully set forth herein in theirentirety.

FIELD OF INTEREST

The current invention relates to implantable apparatuses for accuratelypositioning a medical device within the main pulmonary artery, and tomethods of use thereof for treating, reducing the severity of, orreducing symptoms associated with, or any combination thereof,congestive heart failure, including left ventricular failure, whereinuse may in certain embodiments, affect the position and function of theinterventricular septum during systole.

BACKGROUND OF THE INVENTION

Congestive heart failure (CHF) means the heart does not pump outsufficient blood to meet the body's demands. CHF can result from eithera reduced ability of the heart muscle to contract (systolic failure) orfrom a mechanical problem that limits the ability of the heart'schambers to fill with blood (diastolic failure). When weakened, theheart is unable to keep up with the demands placed upon it and the leftventricle (LV) gets backed up or congested—hence the name of thedisorder. CHF is a progressive disease. Failure of the left side of theheart (left-heart failure/left-sided failure/left-ventricle failure) isthe most common form of the disease.

CHF affects people of all ages including children, but it occurs mostfrequently in those over age 60, and is the leading cause ofhospitalization and death in that age group. Current treatments of CHFinclude lifestyle changes, medications, and surgery to bypass blockedblood vessels, replace regurgitant or stenotic valves, install stents toopen narrowed coronary vessels, install pump assist devices ortransplantation of the heart.

Normal cardiac contraction is a finely tuned orchestrated activitydependent on muscle function, ventricular geometry and loadingconditions termed preload and afterload. When CHF due to LV systolicfailure occurs it is typically associated with changes in the geometryof the ventricles, often called remodeling. The LV becomes dilated andthe interventricular septum is deflected into the right ventricle (RV),resulting in decreased LV output/pumping efficiency. Compare FIG. 1Awith FIG. 1B. The efficient systolic function of the LV is dependent notonly on the strength of the myocardium but also on the LV geometry, theposition and shape of the interventricular septum and the geometry andfunction of the RV. Interventricular dependence has been documented inexperimental studies which have evaluated both normal and pathologicalpreparations in animals. LV systolic function can be directly influencedby interventions affecting the RV and the position of theinterventricular septum.

Surgical pulmonary artery banding (PAB) is a technique that wasdescribed more than 60 years ago and is still in use today for childrenand infants with congenital heart defects, such as overflow of blood tothe lungs and volume overload of the LV. PAB is typically performedthrough a thoracotomy and involves wrapping a band around the exteriorof the main pulmonary artery (MPA) and fixing the band in place, oftenwith the use of sutures. Once applied, the band is tightened, narrowingthe diameter of the MPA, increasing resistance to flow, reducing bloodflow to the lungs, and reducing downstream pulmonary artery (PA)pressure.

Surgical PAB procedures involve the risks present with all surgicalprocedures. In addition, use of PAB has a number of particulardisadvantages and drawbacks. Primary among these drawbacks is theinability of the surgeon performing the procedure to accurately assess,from the hemodynamic standpoint, the optimal final diameter to which thePA should be adjusted. Often, the surgeon must rely upon his or herexperience in adjusting the band to achieve acceptable forward flowwhile decreasing the blood flow sufficiently to protect the pulmonaryvasculature.

It is also not uncommon for the band to migrate towards one of the mainpulmonary branches (usually the left), resulting in stenosis of theother main pulmonary branch (usually the right). There have also beenreports of hardening of the vessels around the band due to buildup ofcalcium deposits and scarring of the PA wall beneath the band, which canalso inhibit blood flow. Flow resistance due to PAB may change overtime, and additional surgeries to adjust band tightness occur in up toone third of patients. The band is typically removed in a subsequentoperation, for example, when a congenital malformation is corrected inthe child or infant.

In addition to the classical use of PAB for treatment of congenitaldefects in infants and children, there has been a recent report of useof surgical PAB for left ventricle dilated cardiomyopathy (LVDCM) ininfants and young children. This method includes increasing the pressureload on the right ventricle by placing a band around the pulmonaryartery. The increased pressure in the right ventricle caused a leftwardshift of the interventricular septum and improvement of left ventriclefunction. It was found that the optimal degree of constriction wasachieved when the RV pressure was approximately 60% to 70% of thesystemic level and so that the interventricular septum slightly moved toa midline position. The success of these procedures in infants andchildren has been reported to be possibly due to the potential formyocyte recovery and repopulation being significantly greater forinfants and young children than for adults. However, it is the positionof the inventors that the geometric improvements to the failing heartdue to PAB may be responsible, at least partially, for the observedimprovements in LV function, and therefore PAB for adult left ventricleheart failure may demonstrate similar improvement in LV function.

It would be desirable to provide a relatively simple PAB device whichcould be implanted in a minimally-invasive fashion, and which wouldallow for later adjustment of blood flow through a vessel. Gradualreduction in the diameter of the MPA may be desirable, but is notcurrently feasible with the surgical PAB approaches described above. Inaddition, it would be desirable to use PAB for treatment of the matureadult population suffering from left ventricle (LV) failure.

Attempts have been made to create adjustable or less invasive solutionsto PAB devices. The FloWatch®-PAB device (Leman Medical Technologies SA)was designed to be surgically implanted around the exterior of the MPAin infants and uses a remote control system in order to make repeatedadjustments of the level of constriction of the implanted device withoutadditional surgical interventions.

The MPA is not a favorable location for positioning an implant due toits large diameter (˜30 mm) and short length (˜50 mm). The full lengthof the MPA is not usable for an implant due to the proximity to thepulmonary valve on one end, and the bifurcation to the pulmonarybranches on the other. It is estimated that the usable length of the MPAfor the implant is approximately 30 mm. Implantation of a short, widedevice into the MPA is very difficult, and there is significant dangerthat the device will rotate or otherwise not be placed concentric withthe MPA, in which case near complete blockage of the MPA could occur. Inaddition, the device may erroneously be placed either too close to thepulmonary valve or the bifurcation.

The apparatuses of this invention include an anchor frame that anchorsthe apparatus within a PA branch vessel, which then assists with theaccurate positioning of a device frame that may include a medical devicewithin the MAP. Because an apparatus of this invention is deliverable bytranscatheter procedure, high risk surgery is avoided. Apparatuses ofthis invention may be used for treatment of CHF in adults, including LVfailure. The apparatuses of this invention may remain in place for anextended time period and may adjustably control the constriction of theMPA for the duration of a therapeutic treatment.

SUMMARY OF THE INVENTION

In one embodiment, this invention provides an apparatus comprising: (a)an anchor frame for placement in a branch pulmonary artery; (b) a deviceframe for placement in the main pulmonary artery (MPA); and (c) aconnecting section; wherein the anchor frame, the device frame and theconnecting section comprise a single entity, an apparatus frame, whereinthe anchor frame comprises one section of the apparatus frame, thedevice frame comprises another section of the apparatus frame, and theconnecting section connects the anchor frame and the device frame of theapparatus frame, and wherein the anchor frame is used to position thedevice frame within the MPA when the apparatus is in an expandedposition.

In one embodiment an anchor frame is placed in the left pulmonaryartery. In one embodiment, an anchor frame further comprises aprotrusion which extends into the right pulmonary artery when theapparatus is in an expanded position.

In another embodiment, an anchor frame is placed in the right pulmonaryartery.

In one embodiment, an anchor section, or a connecting section or adevice section, or any combination thereof of an apparatus frame of thisinvention comprises a zig-zag format, a stent-like format, an open-weaveformat, a lattice format, radially arranged strands, a crisscrossformat, or at least one strut, or any combination thereof.

In one embodiment, an apparatus of this invention is deliverable in acollapsed configuration by a transcatheter procedure.

In one embodiment, a device frame of this invention further comprises amedical device. In one embodiment, a medical device may be selected fromthe group comprising a flow restrictor, a valve, a filter, a pacemaker,a sensor or a drug delivery platform.

In one embodiment, a flow restrictor comprises at least one inflatableballoon. In another embodiment, an at least one inflatable balloon maybe at least 5 inflatable balloons. In one embodiment, an inflatableballoon comprises a toroidal shaped balloon. In another embodiment, aninflatable balloon comprises a circular balloon. In one embodiment, anat least one inflatable balloon is centered within the MPA. In anotherembodiment, an at least one inflatable balloon is concentric with theMPA.

In one embodiment, the inflation/deflation state of the at least oneballoon is able to be adjusted for an extended time period followingimplantation of the apparatus in a subject. In one embodiment theinflation or deflation state of an at least one balloon allows foradjustment of the effective diameter reduction within the MPA.

In one embodiment, an effective diameter reduction comprises a range ofabout 0% to about 100% compared with the MPA without an implanteddevice, wherein 0% comprises a fully open state and 100% comprises afully closed state, wherein a percent greater than 0% and less than 100%comprises a partially open state. In one embodiment, an effectivediameter reduction comprises a range of about 10% to about 90%, or10%-30%, or 30%-70%, or 30%-60%, or 40%-70%, or 50%-60% compared withthe MPA without an implanted device.

In one embodiment, an apparatus frame of this invention isself-expanding. In another embodiment, an apparatus frame of thisinvention is balloon expandable. In another embodiment, an apparatusframe of this invention is self-expanding and balloon expandable.

In one embodiment, this invention provides an apparatus for use in apatient with congestive heart failure. In one embodiment, a patient hasleft ventricular failure and preserved right ventricular function. Inone embodiment, a patient is a human. In one embodiment, a patient is aninfant, a child or an adult.

In one embodiment, an apparatus of this invention may be used to treat,reduce the severity of, delay the onset of, or reduce symptomsassociated with any cardiac or pulmonary condition that requires bloodflow reduction through a pulmonary artery. In one embodiment, a methodof this invention may be used to treat, reduce the severity of, delaythe onset of or reduce symptoms associated with any cardiac or pulmonarycondition that requires blood flow reduction through a pulmonary artery.

In one embodiment, this invention provides an apparatus comprising: (a)an anchor frame for placement in the left pulmonary artery; (b) a deviceframe for placement in the main pulmonary artery (MPA); and (c) aconnecting section, together the anchor frame, the connecting sectionand the device frame comprise a single entity, an apparatus frame,wherein the anchor frame comprises one section of the apparatus frameand the device frame comprises another section of the apparatus frame,and the connecting section connects the anchor frame and the deviceframe of the apparatus frame, and wherein the apparatus frame comprisesNitinol shape-memory alloy and is self-expanding, wherein the deviceframe comprises a flow restrictor device preassembled onto the deviceframe, and wherein the anchor frame is used to position and anchor thedevice frame within the MPA. In one embodiment a flow restrictorcomprises a toroidal shaped balloon, wherein inflation of the balloon isadjustable and controls the effective diameter reduction of the mainpulmonary artery (MPA) during treatment of a congestive heart failurepatient with left ventricular failure and preserved right ventricularfunction. In another embodiment, a flow restrictor comprises an at leastone balloon, wherein the balloon comprises a circular balloon centeredwithin the main pulmonary artery (MPA), wherein inflation of the balloonis adjustable and controls the effective diameter reduction of MPAduring treatment of a congestive heart failure patient with leftventricular failure and preserved right ventricular function. In oneembodiment a flow restrictor comprises a toroidal shaped balloon,wherein said toroidal shaped balloon is concentric with the MPA, whereininflation of the balloon is adjustable and controls the effectivediameter reduction of the main pulmonary artery (MPA) during treatmentof a congestive heart failure patient with left ventricular failure andpreserved right ventricular function. In another embodiment, a flowrestrictor comprises an at least one balloon, wherein the ballooncomprises a circular balloon concentric within the main pulmonary artery(MPA), wherein inflation of the balloon is adjustable and controls theeffective diameter reduction of MPA during treatment of a congestiveheart failure patient with left ventricular failure and preserved rightventricular function. In yet another embodiment, a flow restrictorcomprises more than one balloon, wherein inflation of the balloons isadjustable and controls the effective diameter reduction of the mainpulmonary artery (MPA) during treatment of a congestive heart failurepatient with left ventricular failure and preserved right ventricularfunction.

In one embodiment, this invention provides a method of treating,reducing the severity of, delaying the onset of or reducing symptomsassociated with left ventricular failure in a human comprisingimplanting an apparatus of this invention comprising (a) an anchor framefor placement in a branch pulmonary artery; (b) a device frame forplacement in the main pulmonary artery (MPA); and (c) a connectingsection; wherein the anchor frame, the device frame and the connectingsection comprise a single entity, an apparatus frame, wherein the anchorframe comprises one section of the apparatus frame, the device framecomprises another section of apparatus frame, and the connecting sectionconnects the anchor frame and the device frame of the apparatus frame,and wherein the anchor frame is used to position the device frame withinthe MPA when the apparatus is in an expanded position; wherein thedevice frame comprises an adjustable flow restrictor; the methodcomprising the steps of: implanting the apparatus using transcatheterdelivery such that the anchor frame resides within a branch pulmonaryartery and the device frame resides within the MPA; adjusting the flowrestrictor to reduce the effective diameter of the MPA; whereinimplantation of the apparatus treats, reduces the severity of, delaysthe onset of, or reduces symptoms associated with left ventricularfailure in a human.

In one embodiment, in a method of this invention, an anchor frame isplaced in the left pulmonary artery. In one embodiment, an anchor framefurther comprises a protrusion which extends into the right pulmonaryartery when the apparatus is in an expanded position.

In another embodiment, in a method of this invention an anchor frame isplaced in the right pulmonary artery.

In one embodiment, a method of this invention comprises an apparatusframe wherein an anchor frame, or a connecting section, or a deviceframe, or any combination thereof, comprise a zig-zag format, astent-like format, an open-weave format, a lattice format, radiallyarranged strands, a crisscross format, or at least one strut, or anycombination thereof.

In one embodiment, in a method of this invention a transcatheterdelivery is performed with the apparatus in a collapsed configuration.

In one embodiment, in a method of this invention, an adjustable flowrestrictor comprises at least one inflatable balloon. In anotherembodiment, at least one inflatable balloon comprises at least 5inflatable balloons. In one embodiment an at least one inflatableballoon comprises a toroidal shaped balloon. In another embodiment, anat least one inflatable balloon comprises a circular balloon.

In one embodiment, a method of this invention comprises centering the atleast one inflatable balloon within the MPA.

In one embodiment, a method of this invention comprises an at least oneinflatable balloon wherein the inflation/deflation state of the at leastone balloon is able to be adjusted for an extended time period followingimplantation of the apparatus in the human adult. In one embodiment, theinflation or deflation state of the at least one balloon allows foradjustment of the effective diameter reduction within the MPA.

In one embodiment, a method of this invention comprises an effectivediameter reduction of the MPA, comprises a range of about 0% to about100% compared with the MPA without an implanted device, wherein 0%comprises a fully open state and 100% comprises a fully closed state,wherein a percent greater than 0% and less than 100% comprises apartially open state. In one embodiment, an effective diameter reductioncomprises a range of about 10% to about 90% compared with the MPAwithout an implanted device. In one embodiment, an effective diameterreduction comprises a range of about 10% to about 30% compared with theMPA without an implanted device. In one embodiment, an effectivediameter reduction comprises a range of about 30% to about 70% comparedwith the MPA without an implanted device. In another embodiment, aneffective diameter reduction comprises a range of about 30% to about 60%compared with the MPA without an implanted device. In yet anotherembodiment, effective diameter reduction comprises a range of about 40%to about 70% compared with the MPA without an implanted device. In oneembodiment, an effective diameter reduction comprises a range of about50% to about 60% compared with the MPA without an implanted device.

In one embodiment a method of this invention further comprises the stepof adjusting step-wise the inflation state of the at least one balloon.In one embodiment, an at least one balloon is connected to an inflationtube. In one embodiment, a method of this invention further comprisesattaching the proximal end of the inflation tube to a subcutaneouslyimplanted port after implantation of the apparatus. In one embodiment, amethod of this invention further comprises injecting or withdrawing afluid through the port resulting in inflation and/or deflation of the atleast one balloon. In one embodiment, a fluid is a saline solution.

In one embodiment of a method of this invention, an adjustable flowrestrictor is preassembled and attached to the device frame prior toapparatus implantation. In one embodiment, an apparatus frame isself-expanding. In one embodiment, an apparatus frame is balloonexpandable.

In another embodiment, an apparatus frame of this invention isself-expanding and balloon expandable.

In one embodiment, a method of this invention is for use with a humaninfant, a human child or a human adult.

In one embodiment, this invention provides a method of repositioning,supporting or repositioning and supporting the interventricular septumin a LV failure patient comprising implanting an apparatus comprising:(a) an anchor frame for placement in a branch pulmonary artery; (b) adevice frame for placement in the main pulmonary artery (MPA); and (c) aconnecting section; wherein the anchor frame, the device frame and theconnecting section comprise a single entity, an apparatus frame, whereinthe anchor frame comprises one section of the apparatus frame, thedevice frame comprises another section of apparatus frame, and theconnecting section connects the anchor frame and the device frame of theapparatus frame, and wherein the anchor frame is used to position thedevice frame within the MPA when the apparatus is in an expandedposition; wherein the device frame comprises an adjustable flowrestrictor; the method comprising the steps of: implanting the apparatususing transcatheter delivery such that the anchor frame resides within abranch pulmonary artery and the device frame resides within the MPA;adjusting the flow restrictor to reduce the effective diameter of theMPA; wherein implantation of the apparatus in a human repositions,supports or repositions and supports the interventricular septum in a LVfailure patient.

In one embodiment, this invention provides a method of treating,reducing the severity of, delaying the onset of or reducing symptomsassociated with left ventricle failure in an adult subject, said methodcomprising pulmonary artery banding (PAB). In another embodiment, PABcomprises external PAB. In another embodiment, PAB comprisesintravascular PAB.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

The subject matter regarded as the invention is particularly pointed outand distinctly claimed in the concluding portion of the specification.The invention, however, both as to organization and method of operation,together with objects, features, and advantages thereof, may best beunderstood by reference to the following detailed description when readwith the accompanying drawings in which:

FIGS. 1A-1B depict a bird's eye internal view of the right and leftventricles of the heart and the interventricular septum positionedbetween these chambers. FIG. 1A shows a heart having normal physiology.FIG. 1B illustrates a heart with acute left ventricle (LV) distension,wherein the interventricular septum has deflected into the rightventricle.

FIG. 2 presents a block diagram of one embodiment of the inventionshowing an apparatus frame comprising an anchor frame and a device framewith a connecting section between these two frames.

FIG. 3 presents an illustration of a cross-section of one embodiment ofan apparatus frame, expanded, of this invention, showing an anchor framesection anchored within the left pulmonary artery (LPA) and a deviceframe section positioned in the main pulmonary artery (MPA). Aconnecting section serves to connect the anchor frame with the deviceframe in the area of the branch of the RPA. The device frame section issituated between the pulmonary valve and the PA bifurcation. As seen inthe expanded configuration, the device frame may also serve to anchorthe apparatus frame in place. The right pulmonary artery (RPA) is shownbranching towards the left in the illustration.

FIGS. 4A-4H present illustrations of some embodiments of an apparatus ofthis invention as shown in cross-section in an expanded configuration,wherein the device frame has been implanted within the MPA. FIG. 4Adepicts an anchor frame having a stent-like, or crisscross strand,format connected with a connecting section, in this embodiment includingmultiple struts arranged longitudinally, further connected to a deviceframe having a different stent-like, or zig-zag strand, format. In thisembodiment, the anchor frame has been implanted in the LPA, and theconnecting frame extends through the bifurcation connecting with thedevice frame in the MPA. The connecting section, in one embodiment, mayaccommodate the not completely linear geometry required of an apparatusframe in order to connect an anchor frame in the LPA with a device framein the MPA. In this embodiment, placement of the anchor frame in the LPAanchors and positions the device frame in the MPA. FIG. 4B depictanother embodiment, wherein the anchor frame includes a non-symmetricprotrusion residing in the RPA to prevent downstream movement of theapparatus. In this figure, only a single strut is depicted in theconnecting section, although the connecting section can be made up ofmore struts, a stent-like section, or other formats of a connectingstructure. FIG. 4C depicts an apparatus frame having hooks to hook intothe surrounding vascular wall. Hooks are shown on both the anchor frameand the device frame. In some embodiments, hooks may be present only onthe anchor frame, only on the device frame, or on both the anchor frameand the device frame. FIG. 4D depicts an anchor frame having astent-like configuration connected with a connecting section, shown asincluding a single strut arranged in a mild arc but in general includingother struts or other connecting structure, to a device frame having astent-like configuration. In this embodiment, the anchor frame has beenimplanted in the RPA, and the connecting frame extends along the RPAconnecting with the device frame in the MPA. In this embodiment,placement of the anchor frame in the RPA positions the device frame inthe MPA. FIG. 4E depicts an apparatus frame wherein a circular balloon,which may in one embodiment be tapered at one end as shown here, whereinsaid balloon is tapered in the direction of flow, has been attached tothe anchor frame by struts protruding from the anchor frame. The strutsfunction to keep the balloon centered concentrically in the MPA. FIG. 4Fdepicts an apparatus frame wherein a circular balloon has been attachedto both the anchor frame and the device frame by struts protruding fromboth of these frames. The struts function to ensure that the balloonremains centered concentrically in the MPA. FIG. 4G depicts a toroidalballoon attached to the device frame such that the constriction ballooninflates from the inner vessel wall inwards towards the center line ofthe MPA. As seen in FIG. 4G, in one embodiment, the cross-section of thetoroidal balloon is circular, and in another embodiment, thecross-section of the toroidal balloon is semi-circular (not shown). FIG.4H depicts an apparatus frame showing a toroidal balloon connected tothe device frame, with the balloon, wherein the cross-section of thetoroidal balloon is not circular, but has a more oblong shape. Thus, theballoon has a specific profile that may, for example, cause a forcevector outward towards the wall of the artery, and function to keep theballoon secure against the sides of the MPA vessel.

FIGS. 5A and 5B present illustrations of a cross-section of embodimentsof an expanded apparatus having an anchor frame, a connecting section,and a device frame with a toroidal balloon attached to the device frame(device frame situated behind the balloon in the figure) and positionedwithin the MPA. As shown in FIG. 5A, in one embodiment, the toroidalballoon is partially inflated such that the effective diameter of theMPA in the area of the balloon is smaller than the original diameter ofthe MPA. As depicted in the embodiment of FIG. 5A, the cross-sectionalshape of the balloon is approximately a semi-circle. FIG. 5B shows anembodiment wherein the toroidal balloon is completely deflated, a statecorresponding, for example, to after completion of treatment in whichthe fluid in the balloon is completely removed. An inflation tube isshown attached to the balloon in FIGS. 5A and 5B, and descends along avessel wall of the MPA towards the pulmonary valve. The tube may travelthrough the right side of the heart and through a wall of an upstreamvein at which point it can be attached on its other end (proximal end)to a subcutaneously implanted inflation port to allow for control ofdegree of inflation of the toroidal balloon (port not shown). As usedherein, the term “proximal end” refers in one embodiment to the end, forexample of an inflation tube, closest to the inflation port. As usedherein, the term, “distal end” refers in one embodiment to the end, forexample of an inflation tube, furthest from the inflation port, and inone embodiment, connected to the flow restriction balloon.

FIGS. 5C, 5D and 5E present illustrations of embodiments of an expandedapparatus of this invention implanted within the LPA and MPA, from abottom view of FIGS. 5A and 5B, having an anchor frame, a connectingsection, and a device frame with a toroidal balloon attached to thedevice frame and positioned within the MPA. FIG. 5C shows an embodimentwith the balloon in an inflated state, thereby significantly reducingthe effective diameter of the MPA and creating resistance to blood flowto the lungs. FIG. 5D shows an embodiment with the balloon slightlyinflated, wherein the connecting section may be observed. FIG. 5E showsan embodiment with the balloon completely deflated, wherein the relativepositions of the anchor frame, the connecting section, and the deviceframe of the apparatus may all be observed.

FIGS. 6A-6C present illustrations of an apparatus having an anchorframe, a connecting section, and a device frame (apparatus frameexpanded and implanted within the LPA and the MPA) with multipleballoons attached to the device frame. FIG. 6A is a view with half ofthe vessel wall removed showing an embodiment of an apparatus havingfive small balloons within the device frame wherein the balloons areeffectively implanted around the internal circumference of the MPA. Theapparatus frame is anchored by positioning the anchor frame section inthe LPA, which thereby positions the device frame section in the MPA.The view shown is of an expanded apparatus frame. Thin double lumeninflation tubes are attached to each balloon. FIG. 6B is across-sectional view depicting an embodiment of the apparatus showing2.5 balloons (half of the 5 balloons shown in FIG. 6A) attached to thedevice frame and evenly positioned around the internal circumference ofthe device frame. The device frame is positioned in the MPA. Eachballoon has an inflation tube, which in one embodiment is a double lumentube. One lumen of this tube can be used for inflation of the balloon,while the other lumen houses the guide wire, which could be used forremoval of the balloons after termination of treatment. The inflationtube lumens can remain separate or can all be manifolded into a singleinflation tube attached to a subcutaneous port (not shown). Balloonsshown are in a partially inflated state. A guide wire is shown withinone lumen of one inflation tube and is used for unhooking the balloonfrom the device frame at a device frame attachment site, in order toremove the balloons from the apparatus after treatment. FIG. 6C is across-sectional view of an embodiment of an apparatus showing 2.5balloons (half of the 5 balloons of FIG. 6A) attached to the deviceframe and positioned evenly around the internal circumference of thedevice frame. The device frame is positioned in the MPA. The balloonsare shown in a deflated state with each balloon having a double lumeninflation tube with a guide wire included in one lumen, which connectsthe balloon to the device frame of the apparatus. In one embodiment,this illustration represents an apparatus of the invention followingtermination of the treatment, in which the balloons have been deflatedand are in the process of being removed.

FIG. 6D presents an illustration of a cross-sectional view of anembodiment of an apparatus, expanded, having an anchor frame, aconnecting section, and a device frame with multiple balloons notpresent within the device frame. The inflation tubes, with guide wiresin one of each of the double lumen tubes, are shown after the balloonshave been removed following termination of therapy. The inflation tubesmay remain in place after removal of the balloons, or may subsequentlyalso be unhooked and removed from the apparatus.

FIGS. 6E-6F present bottom view illustrations of embodiments of anexpanded apparatus having an anchor frame, a connecting section, and adevice frame with multiple balloons attached to the device frame, suchas in FIGS. 6A and 6B. FIG. 6E depicts one embodiment of an apparatus,showing the bottom view of the balloons around the internalcircumference of the device frame from below the device frame. Balloonsshown are in an inflated state, thereby significantly reducing theeffective diameter of the MPA and creating resistance to blood flow tothe lungs. Each balloon has a double lumen inflation tube, wherein onelumen is for inflation/deflation and one lumen contains the guide wire.The inflation lumens can remain separate or can all be manifolded into asingle inflation tube attached to a subcutaneous port. FIG. 6F depictsone embodiment of an apparatus, showing the bottom view of balloonsaround the internal circumference of the device frame from below thedevice frame. Balloon shown are completely deflated at the terminationof treatment, prior to removal of the balloons. The double lumeninflation tube associated with each balloon has been indicated.

FIG. 7 presents an illustration of one embodiment of an apparatus,showing a partially inflated toroidal balloon within a device framepositioned within the MPA and anchored by an anchor frame in the LPA,wherein the balloon is attached to an inflation tube, which is furtherattached to a subcutaneous inflation port.

It will be appreciated that for simplicity and clarity of illustration,elements shown in the figures have not necessarily been drawn to scale.For example, the dimensions of some of the elements may be exaggeratedrelative to other elements for clarity.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

In the following detailed description, numerous specific details are setforth in order to provide a thorough understanding of the invention.However, it will be understood by those skilled in the art that thepresent invention may be practiced without these specific details. Inother instances, well-known methods, procedures, and components have notbeen described in detail so as not to obscure the present invention.

Before explaining at least one embodiment of the present invention indetail, it is to be understood that the invention is not limited in itsapplication to the details of construction and the arrangement of thecomponents set forth in the following description or illustrated in thedrawings. The invention is capable of other embodiments or of beingpracticed or carried out in various ways. Also, it is to be understoodthat the phraseology and terminology employed herein are for the purposeof description and should not be regarded as limiting.

Apparatuses

In one embodiment, an apparatus of this invention comprises (a) ananchor frame, (b) a connecting section, and (c) a device frame, whereinthe anchor frame, the connecting section and the device frame togethercomprise a single entity, an apparatus frame, wherein the anchor framecomprises one section of the apparatus frame and the device framecomprises another section of the apparatus frame, and the connectingsection connects the anchor frame with the device frame, and the anchorframe is used to position the device frame within the main pulmonaryartery (MPA). The anchor frame, connecting section and the device frameprovide a platform structure, which in certain embodiments may be in acollapsed or expanded configuration.

As used throughout, the term “platform structure” refers in oneembodiment to an anchor frame section, a connecting section and a deviceframe section of an apparatus of this invention. In some embodiments,the term “platform structure” may be referred to as an “apparatus”,“apparatus frame” or “platform frame” having all the same meanings andqualities.

Reference is now made to FIG. 2 . FIG. 2 presents an embodiment of anapparatus comprising an apparatus frame of the invention in blockdiagram form. The entity includes three sections, an anchor framesection, a device frame section and a connecting section that connectsthe anchor frame with the device frame. Placement of the anchor framesection within a branch of the pulmonary artery anchors and establishesthe placement of the device frame within the MPA. In one embodiment, aconnecting section of this invention can include a zig-zag format, astent-like format, an open weave format, a mesh format, a lattice formator a crisscross format or may include at least one strut, or anycombination thereof (FIG. 3 and FIGS. 4A-H).

As used herein, the term “expanded configuration” refers in oneembodiment to an apparatus frame of this invention after deployment. Inone embodiment, an apparatus frame may be self-expanding followingdeployment. In another embodiment, an apparatus frame may be balloonexpandable following deployment. In another embodiment, an apparatusframe of this invention is self-expanding and balloon expandable. Inanother embodiment, an apparatus frame comprises at least a portionsections that is self-expanding and at least a portion that is balloonexpanding. In another embodiment, self-expanding and balloon expandingportions do not overlap. In an alternative embodiment, self-expandingand balloon expanding portions comprise some overlap. In anotherembodiment, overlap comprises less than about 1% of the apparatus. Inanother embodiment, overlap comprises less than about 5% of theapparatus. In another embodiment, overlap comprises less than about 10%of the apparatus. In another embodiment, overlap comprises less thanabout 20% of the apparatus. In another embodiment, overlap comprisesless than about 30% of the apparatus. In another embodiment, overlapcomprises less than about 40% of the apparatus. In another embodiment,overlap comprises less than about 50% of the apparatus. In anotherembodiment, overlap comprises less than about 60% of the apparatus. Inanother embodiment, overlap comprises less than about 70% of theapparatus. In another embodiment, overlap comprises less than about 80%of the apparatus. In another embodiment, overlap comprises less thanabout 90% of the apparatus. In another embodiment, overlap comprisesabout 100% of the apparatus. As used herein, the term “expandedconfiguration” may be used in some embodiments, interchangeably with“expanded” or “expanded apparatus” or “expanded apparatus frame” orexpanded conformation” having all the same qualities and meanings.

In one embodiment, an anchor frame may be placed in the left pulmonaryartery (LPA). In another embodiment, an anchor frame may be placed inthe right pulmonary artery (RPA). By placing and expanding an anchorframe within a pulmonary artery branch, the device frame section of theapparatus may be accurately positioned within the MPA, ensuringconcentric implantation within the MPA. In one embodiment, an anchorframe further includes a protrusion. When an apparatus of this inventionis implanted such that the anchor frame is place within the LPA, in oneembodiment an anchor frame protrusion extends, asymmetrically, into theRPA to prevent downstream movement of the apparatus. (FIG. 4B) Viceversa, when an apparatus of this invention is implanted such that theanchor frame is place within the RPA, in one embodiment an anchor frameprotrusion extends into the left pulmonary artery to prevent downstreammovement of the apparatus.

Movement of the device frame may be prevented by the placement andexpansion of the anchor frame, as well as the expansion of the deviceframe itself. In one embodiment following deployment of an apparatus ofthis invention, the anchor frame is positioned and released and thispositions the device frame. Future movement is prevented by the radialstrength of the anchor frame and the device frame structures. In anotherembodiment, future movement may be prevented by the use of hooks. In yetanother embodiment, future movement may be prevented by protrusion of ananchor frame into the counter-lateral branch of the PA. Theseembodiments to prevent movement are not exclusive and may be combined,that is, in one embodiment movement may be prevented by the radialstrength of the anchor frame, the radial strength of the device frame,use of hooks associated with the anchor frame, use of hooks associatedwith the device frame, use of hooks associated with the anchor frame andthe device frame, or by a protrusion of an anchor frame into thecounter-lateral branch of the PA, or any combination thereof.

In one embodiment, sutures are not needed to prevent movement of theapparatus of this invention. In one embodiment, tissue hooks are notneeded to prevent movement of an apparatus of this invention.

Reference is now made to FIG. 3 . FIG. 3 depicts, in cross-section, oneembodiment of an apparatus implanted within the pulmonary artery,comprising an anchor frame section, a connecting section and a deviceframe section in its expanded configuration. During deployment, when theanchor frame is expanded within the LPA it exerts pressure on the innerpulmonary artery wall, thereby anchoring the anchor frame within theLPA. The positioning of the anchor frame within the LPA is chosen suchthat it ensures accurate placement of the device frame within the MPA,situated between the PA bifurcation and the pulmonary valve, afterdeployment of the connecting section and the device frame.

The size of the apparatus frame of an apparatus of this invention may betailored to pulmonary artery dimensions present in a CHF patient,wherein the skilled artisan using knowledge of physiology of a subjectcould competently select the proper dimensions of an apparatus of thisinvention for use in a method of this invention.

Methods of measuring the internal diameter of a branch pulmonary arteryand the main pulmonary artery are known in the art, such as byechocardiogram or magnetic resonance imaging (MRI). Therefore, thedimensions of an apparatus, when in an expanded configuration, may bepredetermined by one skilled in the art.

In one embodiment, slight oversizing of the diameter of the platformstructure, in its expanded configuration, is sufficient to retain theapparatus in place after deployment in the vessels.

In one embodiment, a device frame may have a diameter, for example in anadult human, of about ˜30 mm, roughly equivalent to the maximum lengththat can be put into the MPA while keeping sufficiently away from thepulmonary valve or the bifurcation so as not to interfere with either.In general, use of any frame with a length to diameter ratio of lessthan ˜2 leads to problems of stable deployment of the device. Problemsmay include potential for the frame to rotate and not sit concentricallywithin the MPA. A worst-case scenario would be for the frame to rotateor move and cause near complete obstruction of the MPA, which couldrequire surgical intervention to correct.

In certain embodiments, this invention overcomes problems of accuratedevice frame positioning with the MPA, and potential for later movementfrom that position. In one embodiment, an apparatus frame of thisinvention uses an anchoring frame connected (through a connectingsection) to the device frame, wherein the anchor frame is place within abranch pulmonary artery, which effectively adds length to the deviceframe and, may in certain instances, prevent the problem of unwantedrotation and non-concentric placement during deployment. In oneembodiment, an apparatus frame of this invention may ensure concentricplacement of the device frame within the MPA.

In one embodiment, wherein an apparatus of this invention is for use ina human adult, dimensions of a platform structure may, for example,comprise a length of about 55 mm (including the anchor frame, connectingsection, and device frame), an expanded diameter of about 16 mm in theanchor frame (in either the LPA or RPA), and an expanded diameter ofabout 30 mm in the device frame (in the MPA). In another embodiment, theapparatus is sized such that the expanded anchor frame is slightlylarger in diameter than the measured branch PA, and the device frame isslightly larger in diameter than the measured MPA, thereby helping toprevent movement of the expanded apparatus.

In one embodiment, an at least one inflated balloon attached to a deviceframe could create an effective MPA diameter of about 15 mm. In anotherembodiment, a partially inflated at least one balloon could create aneffective MPA of less than 15 mm. In one embodiment, to create aneffective MPA diameter of about 15 mm or less than 15 mm, an at leastone inflated balloon may for example be a circular balloon, a toroidalshaped balloon, or multiple balloons, wherein adjustment of theinflation state of these balloons provides for an effective MPAdiameter.

Reference is now made to FIGS. 4A-4H. The apparatus frames illustratedin FIGS. 4A-4H show certain embodiments of the invention. For instance,FIGS. 4A-4H show that the format structure of the strands making up anapparatus frame may differ between the anchor frame, the connectingsection, and the device frame. In these embodiments, the anchor framehas been drawn with a stent-like, or crisscross pattern, format. Otherembodiments may include an anchor frame with a lattice format, an openweave format, longitudinally-arranged strands, a zig-zag format, or astent-like format. Each figure represents another embodiment of anapparatus and of how that apparatus may be implanted, such that thedevice frame is securely positioned within the MPA. As seen in thesefigures, the connecting section may be comprised of strands formed intolongitudinally arranged struts. FIG. 3 and FIGS. 5A-5B and FIGS. 6A-6Bshow in other embodiments a connecting section having a lattice format,an open weave format, a zig-zag format, a crisscross format, or astent-like format. In certain embodiments, as shown throughout FIGS.4A-4H, a device frame may have a zig-zag format. In other embodiments, adevice frame comprises a lattice format, an open weave format, radiallyarranged strands, a crisscross format, or a stent-like format.

FIG. 4A shows an apparatus frame positioned with the anchor frame in theLPA and the device frame positioned in the MPA, in the absence of amedical device attached to the device frame. This could in oneembodiment, represent a time prior to implantation of medical device,for example a balloon. In another embodiment, this could represent atime following termination of a therapy wherein the medical device, forexample a balloon, has been removed.

FIG. 4B shows another embodiment of an apparatus frame that includes anasymmetrical protrusion extending into the RPA to prevent downstreammovement of the apparatus. If needed, an apparatus could also includehooks that penetrate the tissue of the arterial walls and secure theapparatus frame in place, as shown in one embodiment in FIG. 4C.Alternative embodiments, may include hooks only in the anchor frame oronly in the device frame.

FIG. 4D illustrates an embodiment wherein the apparatus has an overallbent configuration as the anchor frame has been implanted in the RPA andis depicted with a single bowed strut, but in general may include otherstruts or connecting structures, attaching this anchor frame with thedevice frame secured within the MPA.

FIGS. 4E and F show embodiments of the apparatus with a circularballoon, wherein struts from the anchor frame (FIG. 4E) or from both theanchor frame and the device frame (FIG. 4F) are used to secure that theballoon in centered concentrically in the MPA. In these embodiments, theflow restrictor is positioned within the MPA such that the blood flowwill be between the balloon and the walls of the MPA. Restriction ofblood flow may be adjusted based on the size and shape of the balloon,which affects the flow of blood. For example, by decreasing theeffective diameter of the MPA with increased inflation of a balloon,flow of blood through the MPA will be reduced.

Positioning of an apparatus of this invention comprising a flowrestrictor comprising an at least one balloon affects the route of bloodflowing through the MPA. Positioning of an at least one balloon mayaffect the path the blood takes and create directional pressures on theat least one balloon along the vascular walls. In one embodiment, an atleast one balloon is centered within the MPA. In another embodiment, anat least one balloon is concentric with the MPA. In alternateembodiments, an at least one balloon is not centered within the MPA.

FIGS. 4G and 4H provide embodiments wherein the flow restrictorcomprises a toroidal balloon positioned in the inner circumference ofthe MPA, wherein blood flow would be through the center opening of theballoon. FIG. 4G shows the toroidal balloon having approximately acircular cross-section, while FIG. 4H shows the toroidal balloon havinga non-circular profile. In another embodiment, a toroidal balloon has anapproximately semi-circular cross-section (FIG. 5A). A balloon asdepicted in FIG. 4H may, for example, cause a force vector outwardtowards the wall of the artery, and function to keep the balloon secureagainst the sides of the MPA vessel.

In one embodiment, an apparatus comprising an anchor frame, a connectingsection and a device frame is composed of any biocompatible materialthat does not interact with the blood. In one embodiment, an apparatuscomprising an anchor frame, a connecting section and a device frame iscomposed of shape memory alloy.

As used herein, the terminology “shape memory alloy” refers to alloyswhich exhibit a shape memory effect. That is, the shape memory alloy mayundergo a solid state phase change via molecular rearrangement to shiftbetween a martensite phase, i.e., “martensite”, and an austenite phase,i.e., “austenite”. In other words, shape memory alloys are metals that“remember” their original shapes.

As is well known for minimally invasive medical procedures, the shapememory alloy may advantageously be designed to as to be stored in adeformed state (collapsed configuration) at room temperature whilereverting to its predefined shape at body temperature (expandedconfiguration).

Shape memory alloys compatible with an apparatus of the invention may bebased on various metals such as iron, copper or nickel, as long as theyare biocompatible. In one embodiment, shape memory alloy is Nitinol,which is made from nickel and titanium in approximately equiatomicamounts or a slight increase of nickel. A description of Nitinol may befound, inter alia, in U.S. Pat. No. 4,425,908 whose contents areincorporated herein by reference. Small changes [less than 1%] in thepercentage of nickel in the alloy confer large changes in the propertiesof the alloy, particularly with respect to the transformationtemperature. In one embodiment, a Nitinol alloy will comprise a weightpercentage of 55-56% nickel in order to have shape memory andsuperelastic properties at body temperature. In one embodiment, a shapememory alloy will comprise 55.1-55.6% nickel.

In one embodiment, an apparatus of this invention is in a collapsedconfiguration, wherein the apparatus is deliverable by a transcatheterprocedure. In one embodiment, wherein the anchor frame, connectingsection and the device frame of an apparatus of this invention arecomposed of a shape memory alloy, such as Nitinol, and the apparatus isconfigured to form a collapsed configuration, the apparatus isdeliverable by a transcatheter procedure, and spontaneously changes toform an expanded configuration within the vessels after deployment. Suchan apparatus is called a “self-expanding” apparatus.

In one embodiment, an apparatus frame or a section thereof of thisinvention does not comprise shape memory alloy materials. In oneembodiment, an apparatus frame, or a section thereof, may be made ofstainless steel. In another embodiment, an apparatus frame or a sectionthereof, may be made of any biocompatible metallic material. In oneembodiment, an apparatus frame or section thereof is not comprised of aself-expanding material.

In an alternate embodiment, an apparatus frame or section thereof iscomprised of a non-self-expanding material. In certain embodiments,wherein an apparatus frame or a section thereof is not comprised of aself-expanding material, the apparatus or sections thereof may beexpanded using an at least one inflatable high-pressure balloon. In oneembodiment, an apparatus frame is balloon expandable. In certainembodiments, an apparatus frame of the invention may be delivered usinga transcatheter method and upon placement in the proper positionexpanded to an expanded configuration. In some embodiments, an apparatusframe comprised of shape memory alloy expands upon placement in a properposition. In another embodiment, an at least one high pressure balloonis used to expand an apparatus frame or sections thereof once it hasbeen positioned.

In one embodiment, a device frame of this invention comprises a medicaldevice. The platform formed from the anchor frame, the connectingsection and the device frame supports the medical device, providing astable platform from which it may function. The medical device may bemounted on, attached to or integrally part of the device frame. In oneembodiment, an apparatus of this invention fixes the medical device inplace by exerting pressure on the inner pulmonary artery walls when theanchor frame, connecting section and the device frame are in theirexpanded configurations.

As used herein, the term “attached” refers to one element, for example amedical device being connected or joined to something, for example, adevice frame. In one embodiment, an attachment is permanent. In oneembodiment, an attachment is reversible. In one embodiment, a medicaldevice is permanently attached to a device frame. In another embodiment,a medical device is an integral part of a device frame. In yet anotherembodiment, a medical device may be reversibly attached to a deviceframe. In the case of a medical device being reversibly attached, thedevice may be mounted to the device frame prior to implantation, duringimplantation or following implantation. In one embodiment, wherein amedical device, for example a balloon, is attached to a device frameprior to delivery and implantation, the balloon would be in a deflatedstate and may be permanently or reversibly attached to the device frame.In one embodiment, a medical device may be un-attached from the deviceframe following the end of a therapeutic use of the apparatus.

In one embodiment of this invention, a medical device, for example aballoon may be attached to the device frame by being sewn onto theframe. In another embodiment, a medical device, for example a balloonmay be attached by heat sealing wherein the balloon is sealed to thedevice frame. A medical device may be attached to the interior of adevice frame using any means known in the art to be a secure attachmentand to be bio-compatible for implantation in a human.

In one embodiment, a medical device is selected from the groupcomprising a flow restrictor, a valve, a filter, a pacemaker, a flowsensor or a drug delivery platform. In one embodiment, an apparatus ofthis invention comprising a medical device functions as an internalpulmonary artery band for use in the treatment of congestive heartfailure (CHF).

In one embodiment, a medical device comprises a flow restrictor. In oneembodiment, a medical device consists essentially of a flow restrictor.In one embodiment, a medical device consists of a flow restrictor.Placement of a flow restrictor within the MPA may, in one embodiment,decrease the effective internal diameter of the MPA. In anotherembodiment, placement of a flow restrictor within the MPA may increasethe resistance of blood flow to the lungs. In yet another embodiment,placement of a flow restrictor within the MPA may increase the afterloadof the right ventricle. In still another embodiment, placement of a flowrestrictor within the MPA may increase the pressure in the rightventricle. In still another embodiment, placement of a flow restrictorwithin the MPA may reposition the interventrical septum to achieve amore normal physiological position. In other words, placement of theflow restrictor would correct the right-shift of the septum due to leftventricular failure. In a further embodiment, placement of a flowrestrictor within the MPA may improve left ventricular function. In oneembodiment, placement of a flow restrictor within the MPA may provide acombination of any and all of the effects described herein. Theseembodiments need not be exclusive of one another, and combinations ofeach may be possible.

In one embodiment, a flow restrictor comprises at least one inflatableballoon. In another embodiment, a flow restrictor comprises at least twoinflatable balloons. In yet another embodiment, a flow restrictorcomprises at least three, or four, or five or seven inflatable balloons.In one embodiment, a flow restrictor comprises at least five inflatableballoons. In still another embodiment, a flow restrictor comprises atleast ten or more inflatable balloons.

Balloons may be inflated to form numerous pre-ordained shapes as knownin the art. In one embodiment a flow restrictor comprises a toroidalshaped balloon. A toroidal balloon may, in one embodiment, has acircular cross-section. In another embodiment, a toroidal balloon has anon-circular cross section.

In another embodiment, a flow restrictor further comprises a cover. Forexample, in another embodiment an at least one balloon further comprisesa cover. In another embodiment, a flow restrictor is a covered balloon.In some embodiments, methods of use of a covered flow restrictor devicecreates gradual changes in diameter, prevent eddy currents of bloodaround the balloons, or allows greater control over material selectionfor biocompatibility, hemocompatibility, etc., or any combinationthereof. In certain embodiments, methods of use of a covered ballooncreates gradual changes in diameter, prevent eddy currents of bloodaround the balloons, or allows greater control over material selectionfor biocompatibility, hemocompatibility, etc., or any combinationthereof.

Reference is now made to FIGS. 5A-5E. FIG. 5A depicts, in cross-section,an anchor frame, a connecting section, and a device frame, in anexpanded configuration wherein a toroidal balloon flow restrictor isattached on the inner circumference of the device frame. The expandedanchor frame placed in the LPA positions the toroidal balloon attachedto the device frame within the MPA. Attached to the balloon is aninflation tube, wherein the distal end of the inflation tube is attachedto the balloon. The inflation tube may descend along the vessel wall ofthe MPA, through the pulmonary valve and the right side of the heart,and through a vein feeding the right atrium. The proximal end of theinflation tube may be attached to a subcutaneously implanted inflationpoint to allow for control or the degree of inflation of the toroidalballoon (FIG. 7 ).

In one embodiment of this invention an inflation tube is attached to aninflatable balloon at its distal end and attached to an inflation portat its proximal end. In one embodiment, the attachment of the inflationtube to a balloon is permanent. In another embodiment, the attachment ofthe inflation tube to a balloon is reversible. In one embodiment, theattachment of the inflation tube to an inflation port is permanent. Inanother embodiment, the attachment of the inflation tube to an inflationport is reversible. The toroidal balloon illustrated in FIG. 5A has beenpartially inflated. FIG. 5B depicts, in cross-section, one embodiment ofthe invention, showing a completely deflated toroidal balloon attachedto the device frame within the MPA.

In one embodiment, an inflation tube is a thin inflation tube. In someembodiments, an inflation tube of this invention comprises a hollow tubemade of a polymer, which in certain embodiments is a flexible polymerwith limited interference for the vessels and valves through which it isdeployed. In one embodiment, an inflation tube has a single lumen. Inanother embodiment, an inflation tube has two lumens, one for inflationand one for use with a guide wire.

In one embodiment, an inflation tube is attached to/detached from asubcutaneously implanted inflation port by pushing/pulling the inflationtube. In another embodiment, an inflation tube is attached to/detachedfrom an inflation port by screwing/unscrewing the inflation tube. In yetanother embodiment, an inflation tube is attached to/detached from aninflation port by electrolysis or other mechanical or chemical means.

In one embodiment, an inflation port may be implanted subcutaneouslywithin a subject concurrently with implantation of an apparatus. Inanother embodiment, an inflation port may be implanted within a subjectprior to implantation of an apparatus. In one embodiment, an inflationport may be removed from a subject at the termination of a therapy. Inanother embodiment, an inflation port may be left in place at thetermination of a therapy. The inflation tubes may be detached from theinflation port or may remain in place.

In one embodiment, the inflation state of an at least one balloon isadjustable. In one embodiment, adjustments may be made at the time ofimplantation or during a therapeutic treatment or any combinationthereof. In one embodiment, adjustments may be made at the terminationof a therapy, for example completely deflating an at least one balloon.In some embodiments, wherein an apparatus of this invention is left inplace, it may be possible to inflate an at least one balloon at a laterdate dependent on the need of a subject patient. In one embodiment,adjustments to the inflation state of an at least one balloon arecontrolled from the inflation port by the introduction or removal of afluid solution, for example a saline solution. In another embodiment,the at least one balloon is adjustable at any time after implantation.In yet another embodiment, the at least one balloon is adjustable onlyat time of implantation. In still another embodiment, the at least oneballoon is not adjustable.

In one embodiment, inflation of a balloon may reduce the effectivediameter of the MPA, creating a resistance to blood flow to the lungs.FIG. 5C depicts, in a bottom view, a partially inflated toroidal balloonattached to a device frame, from below the MPA. The effective diameterof the MPA has been significantly reduced. The anchor frame of theapparatus shown in FIG. 5C has been placed in the LPA (not observablefrom this angle). The device frame is observable as a thin ring and theRPA is seen extending leftward. FIG. 5D depicts, in a bottom view, anapparatus as is shown in FIG. 5C, wherein the balloon is in a lessinflated state. The decreased inflation reveals the connecting sectionresiding between the LPA and the MPA. FIG. 5E depicts, in a bottom view,an apparatus wherein the toroidal balloon has been completely deflated.

Reference is now made to FIGS. 6A 6E and 6F. FIG. 6A depicts anapparatus, wherein the anchor frame is placed in the LPA, the connectingsection connects between the anchor frame and the device frame, thedevice frame is positioned within the MPA and five small balloons havebeen attached around the inner circumference of the device frame,effectively placing the five balloons in a donut-like shape within theinner circumference of the MPA (See FIG. 6E-6F). FIG. 6E shows a bottomview of an embodiment of this invention, wherein an apparatus comprisesan anchor frame placed in the LPA, a connecting section connects betweenthe anchor frame and the device frame, a device frame positioned in theMPA and having five small balloons attached to the device frame andarranged around the inner circumference of the device frame. Balloonsshown are in the inflated state, thereby effectively reducing theeffective diameter of the MPA and creating resistance to blood flow tothe lunges. The attached double lumen inflation tubes can be seenextending from each balloon. The lattice of the connecting section canbe observed between the balloons while the device frame is observable ina thin ring around the balloons.

In FIG. 6A half the vessel wall has been removed from the illustration,in order to show the arrangement of balloons. At one region of theballoons, the balloons are attached to the device frame while at anotherregion of the balloons, the balloons are attached to inflation tubes. Inanother embodiment, each balloon can be attached to the device frame atmore than one point on the balloon. In certain embodiments, wherein morethan a single balloon is attached to a device frame, and wherein eachballoon is also attached to an inflation tube, the inflation tubes maybe manifolded together to form a single tube prior to attachment to animplanted subcutaneous inflation port (not shown). In this manner,balloons may be concurrently inflated or deflated. In other embodiments,wherein more than a single balloon is attached to a device frame, andwherein each balloon is also attached to an inflation tube, theinflation tubes remain separate and attach separately to subcutaneousinflation ports. In this instance, balloons may be inflated or deflatedindependent of one another. The attachment to the subcutaneous port maybe permanent or revisable.

In one embodiment, a flow restrictor of this invention comprisingmultiple balloons creates a particular geometry within the MPA. Ageometry created by multiple balloons may be advantageous in regulatingblood flow. In one embodiment, a flow restrictor may comprise twoballoons joined together end to end forming ring, similar to hot-dogsjoined end to end when inflated.

In one embodiment, inflation and/or deflation of an at least one balloonof this invention comprises injecting or withdrawing a fluid through theinflation port. In one embodiment, the fluid is an isotonic salinesolution. In another embodiment, a fluid is a glue. In yet anotherembodiment, a fluid may be beads or particles that act as a fluid. Inone embodiment, regulation of inflation/deflation state of an at leastone balloon is by injecting or withdrawing a fluid through the inflationport.

In one embodiment, an at least one balloon of this invention comprise alow-pressure, or compliant balloon. Compliant medical balloons aretypically fabricated from polyurethane, Nylon elastomers, silicon,latex, or other thermoplastic elastomeric material. They typically havethicker wall thickness than high pressure dilatation medical balloons,and burst pressures typically range up to 2 atmospheres of pressure.

In one embodiment, the adjustable inflation of an at least one balloonprovides the ability to adjust the inflation state of the balloon for anextended time period following implantation of said apparatus in asubject. In one embodiment, adjustable inflation allows for adjustmentof the effective diameter within the MPA. In one embodiment, a balloonin a deflated state does not effectively reduce the diameter of the MPA.In one embodiment, wherein a flow restrictor is comprised of multipleballoons, and wherein the balloons are all in a deflated state, there isno effective reduction of the diameter of the MPA.

In one embodiment, an apparatus of this invention is adjustable, whereinan attached medical device, for example an at least one balloon may bedeflated, partially inflated or fully inflated. In another embodiment,the attached medical device is adjustable at any time afterimplantation. In yet another embodiment, the attached medical device isadjustable only at time of implantation. In a further embodiment, theattached medical device is adjustable at the time of termination oftreatment. In still another embodiment, the attached medical device isnot adjustable. In another embodiment, a skilled artisan may regulatethe extent to which the diameter of the MPA is reduced by partiallyinflating balloon(s), fully inflating balloon(s), fully deflatingballoon(s), or having balloon(s) at different states of inflation.

In one embodiment, the effective reduction of the MPA diameter isdirectly related to the inflation state of an at least one balloon ofthis invention. As used herein, the phrase “effective reduction indiameter” refers to the percent reduction in diameter of the MPA in thearea of the inflated balloon. For example, in an embodiment wherein amedical device is an at least one balloon and the balloon is fullydeflated the effective diameter of the MPA is essentially the diameterprior to placement of an apparatus minus the thin circumference of thedevice frame. In other words, the effective reduction in diameter isabout 0%.

In one embodiment, an effective reduction in diameter comprises a rangeof about 0% to about 100%, wherein 0% comprises a fully open state and100% comprises a fully closed state, wherein a percent constrictiongreater than 0% and less than 100% comprises a partially open state. Inone embodiment an effective reduction in diameter comprises a range ofabout 10% to about 90%. In another embodiment, an effective reduction indiameter comprises a range of about 40% to about 70%. In yet anotherembodiment, an effective reduction in diameter comprises a range ofabout 10% to about 20%. In still another embodiment an effectivereduction in diameter comprises a range of about 20% to about 30%. In afurther embodiment, an effective reduction in diameter comprises a rangeof about 30% to about 80%, or about 30% to about 70%, or about 40% toabout 70%, or about 50% to about 70%, or about 50% to about 60%. In oneembodiment, an effective reduction in diameter is about 10%, 20%, 30%,40%, 50%, 60%, 70%, 80% or 90%.

Reference is now made to FIGS. 6B-6D. In one embodiment, a medicaldevice is attached to a device frame of an apparatus, wherein the deviceframe is positioned within the MPA. In one embodiment, a balloon isattached to the device frame of an apparatus. FIG. 6B shows, incross-section, multiple balloons partially inflated and attached to amedical device by guide wires that extend through one of the lumens ofthe inflation tube (not the lumen used for inflation) and through theballoon to attach the balloon to the device frame at an attachment site.In one embodiment, as shown here, the guide wires hook onto the deviceframe. FIG. 6C shows another embodiment of the apparatus of FIG. 6B,wherein all of the balloons are deflated. Note the presence of the guidewire within the deflated balloons. In one embodiment, guide wiresthreaded through a balloon and through a lumen of the inflation tube,which is not the lumen for inflation, could be attached to the deviceframe prior to deployment of the apparatus in the MPA. In anotherembodiment, guide wires threaded through a balloon and through aninflation tube (in a separate lumen than that used from inflation) couldbe attached to the device frame at the time of implantation or followingimplantation of a platform frame prior to balloon inflation. In oneembodiment, the guide wires extend for the entire length of the doublelumen inflation tube, and terminate at the subcutaneous inflation port,for later use in unhooking and removing the balloons after terminationof treatment. In one embodiment, guide wires may be made of anybiocompatible material known in the art able to secure a balloon to anapparatus frame.

Sites of attachment, for example for guide wires, may be around thecircumference of the device frame, as shown in FIGS. 6B and 6C.Alternatively, a balloon could be stitched to the device frame or heatsealed to the device frame. Each balloon in FIGS. 6B and 6C has a doublelumen inflation tube, the inflation lumen of which can each remainseparate or they can all be manifolded into a single inflation tubeattached to a subcutaneous port. FIG. 6D depicts, in cross-section, anapparatus comprising an anchor frame, a connecting section, a deviceframe and the attached guide wires. This illustrates, in one embodiment,an apparatus of this invention during the process of removal ofballoons. Balloons may be removed from the guide wires or together withthe guide wires after termination of therapy. FIG. 3 shows, in oneembodiment a cross-section of an apparatus of this invention, whereinthe guide wires and balloons have been removed from the device frameafter termination of therapy.

In one embodiment, attachment of a guide wire is reversible. In anotherembodiment, attachment of a guide wire is permanent. In one embodiment,attachment of a medical device comprises guide wires. In one embodiment,attachment of a balloon device comprises guide wires.

In one embodiment, an apparatus comprising a medical device, comprisinga flow restrictor, comprising an at least one balloon, comprises guidewires located within the at least one balloon.

In some embodiments, an apparatus comprises a medical device, comprisinga flow restrictor, comprising at least one balloon, wherein the at leastone balloon is attached to the device frame in a deflated state prior toimplantation of the apparatus or at the end of a treatment therapy.

In one embodiment, a medical device is assembled onto the device duringimplantation, attaching the medical device to the device frame followingpositioning of the device frame within the MPA.

In one embodiment, a medical device is detached from the device frameand withdrawn from the implantation site at the end of a treatmenttherapy.

In one embodiment, an apparatus of this invention comprising an anchorframe, a connecting section and a device frame are self-expanding. Inthis embodiment, the apparatus is configured to form a collapsedconfiguration within the delivery catheter, the apparatus is deliverableby a transcatheter procedure, and spontaneously changes to form anexpanded configuration within the vessels after deployment. In anotherembodiment, an anchor frame is self-expanding. In another embodiment, ananchor frame is balloon expandable. In another embodiment, a deviceframe is self-expanding. In another embodiment, a device frame isballoon expandable. In another embodiment, a connecting section isself-expanding. In another embodiment, a connecting section is balloonexpandable. In another embodiment, an anchor frame is self-expanding,and a device frame is balloon expandable. In another embodiment, adevice frame is self-expanding, and an anchor frame is balloonexpandable.

In one embodiment, an anchor frame, a connecting section and the deviceframe are balloon expandable. In one embodiment, the apparatus isconfigured to form a collapsed configuration within the deliverycatheter, the apparatus is deliverable by a transcatheter procedure, theapparatus is positioned at the desired location in the vessels, and ahigh-pressure balloon is then used to expand the apparatus to form itsfinal expanded configuration within the vessels. In certain embodiments,comprising use of a high-pressure balloon for expansion of an apparatus,the high-pressure balloon is associated with the transcatheter and isnot a component of an apparatus of this invention. The high-pressureballoon is removed following delivery and expansion of the apparatus toan expanded configuration.

In one embodiment, an apparatus of this invention is for use in apatient with congestive heart failure. In one embodiment, a patient hasleft ventricular failure and preserved right ventricular function.

FIG. 7 illustrates one embodiment of an apparatus of this invention,comprising (a) an anchor frame for placement in the LPA; (b) aconnecting section having an open weave pattern, and (c) a device framefor placement in the MPA; wherein together the anchor frame, connectingsection and said device frame comprise a single entity, an apparatusframe, wherein the anchor frame comprises one section of the singleentity and the device frame comprises another section of the singleentity and the connecting section connects the anchor frame with thedevice frame section. In one embodiment, a connecting section may beflexible for example so that the apparatus may include a bend in itsconfiguration following implantation (FIG. 4D). In another embodiment, aconnecting section may be less flexible, for example so that theapparatus remains linear or somewhat linear in its configurationfollowing implantation (FIG. 3 ; FIGS. 4A, 4B, 4C, 4E, 4G, and 4H; FIGS.5A-5E; FIGS. 6A-6F; and FIG. 7 )

In one embodiment, a device frame, connecting section and the anchorframe comprise Nitinol shape-memory alloy and are self-expanding,wherein the device frame comprises a flow restrictor device, comprisinga toroidal balloon, preassembled onto the device frame, and wherein theanchor frame is used to position and anchor the anchor frame in the LPA,thereby positioning and anchoring the device frame within the MPA. Theballoon is attached to the device frame and is further in fluid contactwith a thin inflation tube, wherein the inflation tube is furtherattached to and in fluid contact with a subcutaneously implantedinflation port. Saline or other suitable fluid could be used toadjustably inflate the balloon.

In one embodiment, the flow restrictor comprises a toroidal shapedballoon, for example see FIG. 7 , comprises a low-pressure elastomericballoon, wherein inflation of said low-pressure elastomeric balloon isadjustable at the time of implantation and thereafter and controls theeffective diameter of the main pulmonary artery (MPA) during treatmentof a congestive heart failure patient with left ventricular failure andpreserved right ventricular function.

Methods of Use

Normal cardiac contraction is a finely tuned orchestrated activitydependent of muscle function, ventricular geometry and loadingconditions termed preload and afterload. When congestive heart failure(CHF) due to left ventricular systolic failure occurs it is typicallyassociated with changes in the geometry of the ventricles. The leftventricle becomes dilated and the interventricular septum is deflectedinto the right ventricle (FIGS. 1A and 1B). The efficient systolicfunction of the left ventricle is dependent not only on the strength ofthe myocardium but also on the left ventricular geometry, the positionand shape of the interventricular septum and the geometry and functionof the right ventricle. Increasing flow resistance out of the RV has theeffect of increasing pressing in the RV. This increased RV pressure mayhelp to support and reposition the interventricular septum duringsystolic pumping of the LV. In one embodiment, a method of thisinvention affects the position and function of the interventricularseptum during systole.

In one embodiment, left ventricle failure may be caused by an ischemiccardiomyopathy. In ischemic cardiomyopathy, the heart's ability to pumpblood is decreased because the heart's main pumping chamber, the leftventricle, is enlarged, dilated and weak. This is caused by ischemia—alack of blood supply to the heart muscle caused by coronary arterydisease and heart attacks.

In one embodiment, a method of this invention repositions theinterventricular septum to a more normal anatomical/physiologicalposition by increasing the counter pressure of the RV on the septumwall. In one embodiment, a method of this invention for repositioning,supporting or repositioning and supporting the interventricular septumin a LV failure patient comprises implanting an apparatus of thisinvention, as described in detail above. In certain embodiments, theresult of repositioning, supporting, or repositioning and supporting theinterventricular septum results in more efficient LV pumping, therebytreating, reducing the severity of, delaying the onset of or reducingsymptoms associated with congestive heart failure (CHF), or anycombination thereof.

In one embodiment, a method of this invention comprises treating,reducing the severity of, delaying the onset of or reducing symptomsassociated with left ventricle failure in an adult subject, said methodcomprising pulmonary artery banding (PAB). In another embodiment, leftventricle failure comprises ischemic left ventricular (LV) dysfunction.In another embodiment, left ventricle failure comprises chronic ischemicleft ventricular (LV) dysfunction.

In one embodiment, this invention provides apparatuses, as describedthroughout, which may be used for treating a patient with CHF. CHF maybe due to congenital heart disease, coronary artery disease, high bloodpressure that is not well controlled, heart attack, heart valves thatare leaky or narrowed, or infection that weakens the heart muscle, orany known cause in the art, or any combination thereof.

In one embodiment, an apparatus of this invention may be used to treat,reduce the severity of, delay the onset of, or reduce symptomsassociated with any cardiac or pulmonary condition that requires bloodflow reduction through a pulmonary artery. In one embodiment, a methodof this invention may be used to treat, reduce the severity of, delaythe onset of or reduce symptoms associated with any cardiac or pulmonarycondition that requires blood flow reduction through a pulmonary artery.Pulmonary conditions that require blood flow reduction through apulmonary artery may include conditions with excessive pulmonary bloodflow in order to prevent pulmonary hypertrophy and irreversible (fixed)pulmonary hypertension. Cardiac conditions that require blood flowreduction through a pulmonary artery may include congenital heartdefects such as ventricular septal defects (VSD) and atrioventricularseptal defects (AVSD), wherein there may be one or multiple holes in thewalls separating adjacent chambers. This causes left-to-right shuntingof blood as oxygenated blood can flow back to the right side of theheart, resulting in a mixture of oxygenated and deoxygenated blood.Increased amounts of blood on the right side of the heart cause anexcess of blood flow into the lungs (pulmonary circulation) andincreased pulmonary resistance due to the buildup of pressure.

In one embodiment, a method of this invention is for treating, reducingthe severity of, delaying the onset of or reducing symptoms associatedwith left ventricular failure in an adult human comprising implanting anapparatus comprising: (a) an anchor frame for placement in a branchpulmonary artery; and (b) a device frame for placement in the mainpulmonary artery (MPA); and (c) a connecting section; wherein the anchorframe, and the device frame and the connecting section comprise a singleentity, an apparatus frame, wherein the anchor frame comprises onesection of the apparatus frame, and the device frame comprises anothersection of the apparatus frame, and the connecting section connects theanchor frame and the device frame of the single entity, and wherein theanchor frame is used to position the device frame within the MPA whenthe apparatus is in an expanded position; wherein the device framecomprises an adjustable flow restrictor; the method comprising the stepsof: implanting the apparatus using transcatheter delivery such that theanchor frame resides within a branch pulmonary artery and the deviceframe resides within the MPA; and adjusting the flow restrictor toreduce the effective diameter of the MPA; wherein implantation of theapparatus treats, reduces the severity of, delays the onset of, orreduces symptoms associated with left ventricular failure in an adulthuman.

In certain embodiments, methods of this invention for treating, reducingthe severity of, delaying the onset of or reducing symptoms associatedwith left ventricle failure in an adult subject, comprise pulmonaryartery banding (PAB). In another embodiment, left ventricle failure isdue to congestive heart failure. In another embodiment, left ventriclefailure is due to ischemic damage. In a further embodiment, PABcomprises a reversible process.

In another embodiment, PAB comprises external PAB. In anotherembodiment, external PAB comprises wrapping a band around the exteriorof the main pulmonary artery (MPA) and fixing the band in place. Inanother embodiment, an external band is fixing the band in placecomprises a surgical procedure. In another embodiment, fixing the bandin place comprises sutures. In another embodiment, external PABcomprises use of an inflating band ring. In another embodiment, externalPAB comprises use of an adjustable band. In another embodiment, anadjustable band may be controlled remotely. In still another embodiment,external PAB comprises use of any band known in the art. In anotherembodiment, an external band comprises a biocompatible material.

In yet another embodiment, the PAB comprises an intravascular PAB. Inanother embodiment, intravascular PAB comprises use of a transcatheterdelivery of a device into a pulmonary artery. In another embodiment,intravascular PAB comprises minimally invasive PAB. In anotherembodiment, intravascular PAB comprises use of an apparatus of thisinvention. In another embodiment, the PAB comprises use of an adjustabledevice. Examples of adjustable devices for intravascular administrationare known in the art, for example see U.S. Pat. Nos. 6,120,534 and6,638,257, which are hereby incorporated in their entirety. In anotherembodiment, an adjustable device comprises a balloon. In anotherembodiment, an adjustable band may be controlled remotely. In stillanother embodiment, intravascular PAB comprises use of any device knownin the art. In another embodiment, an intravascular device used for PABcomprises a biocompatible material.

It will be appreciated by a skilled artisan that the term “biocompatiblematerial” as used herein, refers to a material, synthetic or natural,and which remains in intimate contact with living tissue and which doesnot threaten, impede, or adversely affect living tissue.

In another embodiment, an apparatus as described herein may be used fortreating, reducing the severity of, delaying the onset of or reducingsymptoms associated with left ventricle failure in an adult subject.

In one embodiment, as used herein, the term “treating” refers to boththerapeutic treatment and prophylactic or preventative measures, whereinthe object is to prevent or lessen the targeted pathologic condition,for example CHF, as described hereinabove. Thus, in one embodiment,treating may include directly affecting or curing, suppressing,inhibiting, preventing, reducing the severity of, delaying the onset of,reducing symptoms associated with CHF, or a combination thereof. Thus,in one embodiment, “treating” refers inter alia to delaying progression,expediting remission, inducing remission, augmenting remission, speedingrecovery, increasing efficacy of or decreasing resistance to alternativetherapeutics, or a combination thereof. In one embodiment, “preventing”refers, inter alia, to delaying the onset of symptoms, preventingrelapse of CHF symptoms, decreasing the number or frequency of relapseepisodes, increasing latency between symptomatic episodes, or acombination thereof. In one embodiment, “suppressing” or “inhibiting”,refers inter alia to reducing the severity of symptoms, reducing theseverity of an acute episode, reducing the number of symptoms, reducingthe incidence of disease-related symptoms, reducing the latency ofsymptoms, ameliorating symptoms, reducing secondary symptoms, reducingsecondary infections, prolonging a patient survival, or a combinationthereof.

In one embodiment, a method of this invention is for treating, reducingthe severity of, delaying the onset of or reducing symptoms associatedwith left ventricular failure in a human adult patient. In anotherembodiment, a method of this invention is for treating, reducing theseverity of, delaying the onset of or reducing symptoms associated withcongestive heart failure in a human adult patient. In anotherembodiment, a patient is a human child. In yet another embodiment, apatient is a human infant.

In one embodiment, an apparatus of this invention may be implanted in apatient in need. As has been described in the art, in certainembodiments, a catheter may be brought through a vein to the rightatrium, through the tricuspid valve into the right ventricle, and outthrough the pulmonary artery to the start of the branch LPA wheredeployment may commence when the desired location in the LPA isidentified, which ensures proper position of the device frame in theMPA.

As used herein, the term “deployment” refers in one embodiment todelivery of an apparatus of this invention to a desired location; topositioning of the apparatus within that desired position, for examplethe anchor frame in the LPA and the device frame in the MPA; and toexpanding the apparatus at the desired position, for example using aself-expanding metallic frame or a high-pressure balloon-expandingframe; such that the device frame is anchored within the MPA. Followingdeployment, the catheter may be removed, including the high-pressureballoon for expansion, if used.

In one embodiment, an apparatus of this invention may be implanted usinga transcatheter procedure. In one embodiment, implantation comprisesimplanting an apparatus frame. In another embodiment, implantationcomprises implanting an apparatus frame comprising a medical deviceattached to the device frame as describe above. Guide wires and balloonsmay be included with the apparatus at the time of initial implantationor may be implanted at a later date, together or separately.

In one embodiment, an implanted apparatus may remain in place for anextended time period. In certain embodiments, the time-frame that animplanted apparatus remains in place is variable. In some embodiments,the time-frame that an implanted apparatus remains in place correspondsto the length of time, the “duration of a treatment” or the length oftime treatment is needed.

As used herein, the term “duration of treatment” refers in oneembodiment to a time until balloon(s) are completely deflated. Durationof treatment may be determined by a patient's state of health, LVoutput, position of the interventricular septum, or any combinationthereof, or any other medical information determined pertinent bymedical personnel.

In one embodiment, an implanted apparatus remains in place aftertreatment is completed. In one embodiment, an implanted apparatusremains in place indefinitely, wherein the balloon(s) comprised in adevice frame are completely deflated when the duration of treatment hasbeen completed. In one embodiment, treatment is halted, the balloon(s)deflated and the apparatus remains in place. In another embodiment,balloon(s) comprised within a device frame of implanted apparatus areremoved when treatment is complete, while the apparatus frame remains inplace. In another embodiment both the balloon(s) and the apparatus frameare removed when treatment is complete. In one embodiment, if a flowrestrictor comprising an at least one balloon is removed, thesubcutaneous port is also removed at the same time or at a later date.In another embodiment, if a flow restrictor comprising an at least oneballoon remains in place in a deflated state, the subcutaneouslyimplanted port remains in place for potential use at a later date. Inyet another embodiment, if a flow restrictor comprising an at least oneballoon remains in place in a deflated state, the subcutaneouslyimplanted port is removed.

Duration of treatment may differ for each individual patient and fordifferent therapeutic episodes for a single patient. In one embodiment,an implanted apparatus remains in place comprising balloon(s) in aninflation state, or a partially inflated state, wherein the effectivechange of diameter of the MPA is greater than 0% (0% being totallydeflated) for a number of days, for example about 1-8 days. In anotherembodiment, for about a number of weeks, for example 2 weeks, 3 weeks, 4weeks, 5 weeks, 6 weeks, 7 weeks or 8 weeks. In yet another embodiment,for a number of months, for example about 3 months, 4 months, 5 months,6, months, 7, months, 8 months, 9 months, 10 months or 11 months. Instill another embodiment, an implanted apparatus remains in place withballoon(s) in a greater than 0% inflation state for a number of years,for example about 1 year or two years or more. In another embodiment thelength of treatment is indefinite, and continues for as long as there isclinical need.

In one embodiment, only a portion of the apparatus remains in place foran extended time, for example the apparatus frame. In one embodiment,balloons, guide wires, and or inflation tubes, may be implanted and/orremoved over the extended implantation time of the apparatus frame.

In one embodiment, an apparatus of the invention used to treat, forexample CHF, comprises a flow restrictor comprising at least oneballoon, wherein the balloon comprises a low-pressure elastomericballoon, wherein inflation of the low-pressure elastomeric balloon isadjustable and controls the effective diameter of the MPA duringtreatment of the CHF patient with left ventricular failure and preservedright ventricular function.

In one embodiment, an at least one inflatable balloon is inflated basedon a current position of the interventricular septum of a patient.Determining the position of the interventricular septum may be throughany means known in the art, for example through the use of anechocardiogram. Often, the interventricular septum of a patientsuffering LV failure is distended from its more central position intothe right ventricle (RV).

In one embodiment, an at least one balloon of this invention is inflatedwhile medical personnel monitor the position of the interventricularseptum. In another embodiment, an at least one balloon of this inventionis inflated using step-wise adjustments, wherein medical personnelmonitor the position of the interventricular septum before and/or aftereach step-wise adjustment. In one embodiment, an at least one inflatableballoon is inflated or deflated to a state wherein the interventricularseptum is moved slightly back to midline position, closer to what isanatomically/physiologically normal. In one embodiment, the inflationstate of an at least one inflatable balloon, may result in theinterventricular septum moving towards midline position, closer to whatis anatomically/physiologically normal.

Typical RV pressure is about 25% of the LV pressure. Pressure may bemeasured by any means known in the art. For example, a small pressuresensor could be attached to the apparatus frame upstream of the medicaldevice, which in certain embodiments may be an at least one balloon inan inflated or partially inflated state. This upstream sensor wouldprovide the RV pressure. In another embodiment, at least two smallpressure sensors could be attached to the apparatus frame, for exampleone upstream and one downstream of the medical device, which in certainembodiments may be an at least one balloon in an inflated or partiallyinflated state. The upstream sensor would provide the RV pressure, whilethe downstream pressure would provide the PA pressure after the flowconstriction. Together, the differential pressure across the medicaldevice restricting the flow may be determined. Alternately, pressures atdifferent locations may be measured directly by catherization. Pressurecould also be measured by echocardiogram, Doppler ultrasound, or othermethods known in the art.

In some embodiments, an at least one balloon of this invention may beinflated/deflated until pressure in the RV is between 25%-99% of LVpressure. In other embodiments, an at least one balloon of thisinvention may be inflated/deflated until pressure in the RV is between50%-99% of LV pressure. In yet other embodiments, an at least oneballoon of this invention may be inflated/deflated until pressure in theRV is between 50%-75% of LV pressure. In still other embodiments, an atleast one balloon of this invention may be inflated/deflated untilpressure in the RV is between 60%-75% of LV pressure.

Embodiments of this invention may use effective diameter of the MPA as atarget for determining inflation state of a balloon.

In another embodiment, in accessing the use of an apparatus of thisinvention, measurements may be made based on LV cardiac output, whereina skilled practitioner may attempt to increase LV cardiac output,potentially in a step-wise fashion, by increasing obstruction in the MPA(for example: decrease the effective diameter of the MPA by adjustinginflation of an at least one balloon).

In all scenarios, since the inflation of an at least one balloon isadjustable, skilled personnel could proceed inflating an at least oneballoon in step-like fashion: for example, (1) an initial size could beset, followed by (2) a time period of observation of relevantparameters, for instance RV pressure, positioning of the interventricalseptum, or other, and following observation (3) inflation state of an atleast one balloon could be increased or decreased dependent on need.This process may be continued for the duration of a treatment.

In one embodiment, an apparatus of the invention used to treat CHFcomprises a flow restrictor comprises more than one balloon, wherein theballoons comprise low-pressure elastomeric balloons, wherein inflationof the balloons is adjustable and controls the effective diameter of theMPA during treatment of a congestive heart failure patient with leftventricular failure and preserved right ventricular function. Methods ofthis invention may adjustable control the effective diameter of the MPAfor a position of complete openness (0%) change in effective diameter toreduction of the effective diameter to about 40-70% or 50-70% changes,described above in detail. The skilled medical professional, in oneembodiment may adjust the effective diameter of a flow restrictor, forexample a toroidal balloon, in a step-wise fashion. Once implanted, theballoon could be inflated such that the effective diameter is reduced byan initial amount, for example 30%. Observation of heart function couldbe monitored with additional step-wise adjustments being made by theskilled medical professional.

Over time, for example with improvement observed in the patient's heartfunction, including a more physiological positioning of theinterventricular septum, it may be determined that the flow restrictor,for example an at least one balloon, could be deflated step-wise, orcompletely deflated or removed in a single step.

As used herein, in one embodiment, the term “about”, refers to adeviance of between 0.0001-5% from the indicated number or range ofnumbers. In one embodiment, the term “about”, refers to a deviance ofbetween 1-10% from the indicated number or range of numbers. In oneembodiment, the term “about”, refers to a deviance of up to 25% from theindicated number or range of numbers.

As used herein, the term “comprising” is intended to mean that theapparatus includes the recited elements, but not excluding others whichmay be optional. By the phrase “consisting essentially of” it is meantthat an apparatus that includes the recited elements but exclude otherelements that may have an essential significant effect on theperformance of a method of use, for example for treating CHF.“Consisting of” shall thus mean excluding more than traces of otherelements from an apparatus of this invention. Embodiments defined byeach of these transition terms are within the scope of this invention.

In one embodiment, the term “a” or “one” or “an” refers to at least one.In one embodiment the phrase “two or more” may be of any denomination,which will suit a particular purpose.

While certain features of the invention have been illustrated anddescribed herein, many modifications, substitutions, changes, andequivalents will now occur to those of ordinary skill in the art. It is,therefore, to be understood that the appended claims are intended tocover all such modifications and changes as fall within the true spiritof the invention.

All publications, patents and patent applications mentioned in thisspecification are herein incorporated in their entirety by referenceinto the specification, to the same extent as if each individualpublication, patent or patent application was specifically andindividually indicated to be incorporated herein by reference. Inaddition, citation or identification of any reference in thisapplication shall not be construed as an admission that such referenceis available as prior art to the present invention. To the extent thatsection headings are used, they should not be construed as necessarilylimiting. In addition, any priority document(s) of this applicationis/are hereby incorporated herein by reference in its/their entirety.

What is claimed is:
 1. A method of reducing symptoms of congestive heartfailure in a human adult, the method comprising: inserting anintravascular device into a pulmonary artery of a human adult, whereinthe intravascular device is configured to reduce a diameter of a portionof the pulmonary artery; and correcting a right shift of aninterventricular septum of the human adult that has occurred due tocongestive heart failure by selecting a suitable diameter for saiddevice, wherein the correcting is based on reducing the pulmonary arterydiameter with the intravascular device so that pressure in the rightventricle is increased during systole and supports and/or repositionsthe septum.
 2. The method of claim 1, comprising controllably increasingpressure in the right ventricle based on reducing the pulmonary arterydiameter with the intravascular device.
 3. The method of claim 1,comprising controllably increasing flow resistance of the rightventricle based on reducing the diameter with the intravascular device.4. The method of claim 1, comprising reducing symptoms related toischemic damage of the left ventricle based on reducing the diameterwith the intravascular device.
 5. The method of claim 1, comprisingreducing symptoms related to left ventricle failure based on reducingthe diameter with the intravascular device.
 6. The method of claim 1,wherein the reducing is configured to improve systolic function of theleft ventricle based on correcting the right shift of theinterventricular septum.
 7. The method of claim 1, wherein the diameteris configured to be adjustably reduced in vivo.
 8. The method of claim1, wherein the intravascular device is configured to be delivered in acollapsed configuration by a transcatheter procedure.
 9. The method ofclaim 8, wherein the intravascular device is configured to beself-expandable.
 10. The method of claim 8, wherein the intravasculardevice is configured to be balloon expandable.
 11. The method of claim1, comprising anchoring the intravascular device within a branch of thepulmonary artery.
 12. The method of claim 1, wherein said pressure inthe right ventricle is increased during systolic pumping of the leftventricle when providing said supporting and/or repositioning of saidseptum.
 13. The method of claim 1, comprising selecting an adult patientwith a right shift of an intraventricular septum due to a dilated leftventricle and preserved right ventricular function and then performingsaid inserting and said correcting.
 14. The method of claim 1,comprising adjusting said diameter to provide a desired repositioningand/or support of said septum.
 15. The method of claim 1, whereininserting comprises inserting an integral device to extend from a mainpulmonary artery to a branch pulmonary artery.
 16. The method of claim15, wherein said integrated device comprises a plural of struts or amesh interconnecting a section for the main pulmonary artery and asection for the branch pulmonary artery.
 17. The method of claim 1,wherein the method is used to delay the onset of symptoms of leftventricular failure.
 18. The method of claim 1, wherein the methodaffects the position and function of the interventricular septum duringsystole.
 19. The method of claim 1, comprising selecting to apply saidmethod in order to increase an efficiency of left ventricle pumping. 20.The method of claim 1, wherein supporting and/or repositioning comprisesrepositioning the interventricular septum to a more normal/physiologicalposition by increasing a counter pressure of the right ventricle on theinterventricular septum.